Qa Analyst

Company: Trinity Biotech
Location: Niagara Falls
Posted on: November 19, 2022

Job Description:

Reports to: Director of Regulatory/QAEducation Requirements: Technical degree or specific experience in related field with cGMP and ISO9001/13485 or IVD compliance requirements.Experience/Qualifications:Knowledge of cGMP and ISO 9001/13485 systemsAbility to analyze and interpret data and resultsGeneral MS Office computer skills including experience with inventory management systemsAccuracy in recordkeeping and in sorting, checking, counting and verifying itemsProblem solving skills and troubleshooting abilities.Knowledge of product/process validations.Ability to work cooperatively as a member of a team position will interact with multiple operational unitsDetail oriented and good time management skillsExcellent interpersonal, written, and oral communication skills with ability to articulate with accuracy and detail Summary of Position:Individuals serving in this position will be responsible for coordinating quality programs in compliance with ISO 13485 including the CAPA program, supplier quality, and internal audit program.Job Duties/Key Responsibilities:Coordinate the Internal Audit program by creating the internal audit schedule, scheduling audits and following up with any corrective actions required.Manage the CAPA program by logging CAPAs as they occur, conducting monthly CAPA meetings, and guiding the process to completion.Writing and updating quality assurance proceduresEnsure Supplier Quality by qualifying all new vendors, forwarding quality agreements, conducting annual supplier performance evaluation, submitting revisions to the Approved Vendor List (AVL), and conducting supplier audits as needed.Investigate and complete Non-conforming material reports (NCRs)Participate with external (regulatory and customer) auditsCollecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations for management reviewAssist with updating product risk assessments, procedures, reports, etc. as regulations changeProvide recommendations for the improvement of existing processesOther projects as assigned.

Keywords: Trinity Biotech, Niagara Falls , Qa Analyst, Professions , Niagara Falls, New York